Other Complications of Surgical and Medical ProceduresNCT06130527
Comparison of the Effects of Nicardipine and Remifentanil on Surgical Visual Field
A study testing Nicardipine and Remifentanil in people with Other Complications of Surgical and Medical Procedures, run by Erol Karaaslan.
Trial summary
In the present study, the purpose was to compare the effects of Nicardipine and Remifentanil on surgical visual field and hemodynamic parameters in microscopic tympanomastoidectomy cases with Controlled Hypotension (CH). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Other Complications of Surgical and Medical Procedures
- What is being tested?
- Nicardipine and Remifentanil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-II patients of both sexes,
- aged 18-65 years,
- scheduled for tympanomastoidectomy and decided to perform CH,
Who cannot join
- hypertension,
- anticoagulant medication,
- pregnancy
- major hepatic,
- renal,
- cerebral, or cardiorespiratory dysfunction,
Show all 11Show fewer
- neurological or psychiatric disease
- ASA 3-4,
- Body Mass Index BMI≥35 kg/m2,
- difficult intubation was considered (Mallampati score 3-4, a thyromental distance less than 6 cm, maximum mouth opening less than 3 cm),
- the number of intubation attempts more than two, cases with allergies to any of the agents used in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Effects of Nicardipine and Remifentanil on Surgical Visual Field and Hemodynamic Parameters in Tympanomastoidectomy Cases
In the present study, the purpose was to compare the effects of Nicardipine and Remifentanil on surgical visual field and hemodynamic parameters in microscopic tympanomastoidectomy cases with Controlled Hypotension (CH).
Read the detailed description
The visibility of the surgical field provides many advantages (e.g., preventing possible complications and reducing the duration of surgical application). In microsurgery performed in a closed and narrow area (e.g., middle ear surgery), even a small amount of blood may impair the quality of vision in the operation area and complicate the surgical intervention.
Controlled Hypotension (CH) is often preferred in some planned surgeries in reducing intraoperative bleeding, creating a quality surgical field, increasing surgical success, and reducing surgical complications. It is especially important to use it in interventions such as Functional Endoscopic Sinus Surgery (FESS), septoplasty, tympanoplasty, and vertebral surgery performed with microsurgery. As well as the advantages of CH, there is the possibility of causing various side effects by causing target organ hypoperfusion. Cerebral, renal, liver, and cardiovascular systems are the organs most affected by side effects.
Various hypotensive agents such as volatile anesthetics, sympathetic antagonists, sodium nitroprusside, nitroglycerin, hydralazine, trimethaphan, and α2 agonists are used in the literature to provide controlled hypotension.
Nicardipine is a dihydropyridine derivative vasoselective drug. Rapid onset of action i.v. nicardipine is used when rapid control of blood pressure is needed. The potential role of i.v. nicardipine was shown in many cardiovascular and neurovascular surgical procedures and surgical procedures in which CH was performed with hemostasis.
Its dromotropic effect is very low because nicardipine has no significant depressant effect on the conduction system and electrophysiological parameters of the heart. It undergoes substantial presystemic elimination in the liver after oral administration. For this reason, the rate of elimination does not change in patients with kidney failure. The elimination half-life is approximately 2 hours and slows down in patients with hepatic dysfunction.
Many studies investigate the effects of CH on surgical field image quality, surgical satisfaction, bleeding, and hemodynamic parameters. However, in our literature review, no study was detected comparing Nicardipine and Remifentanil in microscopic tympanomastoidectomy cases.
In the present study, the purpose was to compare the effects of controlled hypotension with nicardipine and remifentanil on the quality of surgical field visibility and hemodynamic parameters in endoscopic tympanomastoidectomy cases
- Being tested
- Nicardipine, Remifentanil
- Keywords
- Surgical visual field, nicardipine, remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineProcedure or surgery
Following the intubation, the infusion was initiated by using an infusion device (Orchestra Base Primea, Fresenius Kabi) with an i.v. dose of 1.0 µg/kg/min iv in Group N. The targeted MAP was determined as 50-65 mmHg and drug doses were increased until the targeted MAP was achieved In Group N. Nicardipine infusion will be increased by titration in groups with MAP above 65 mm/Hg for more than 5 minutes.
RemifentanilProcedure or surgery
Infusion was administered i.v. using an infusion device (Orchestra Base Primea, Fresenius Kabi). In Group R, the dose will start at 0.05 µg/kg/min following intubation. The target MAP was determined as 50-65 mmHg and drug doses will be increased until the target MAP is reached. HR more than 120 seconds and less than 45 beats/min will be considered as bradycardia and the remifentanil dose will be reduced. If response is unsatisfactory, 0.5 mg Atropine i.v. will be implemented. Nicardipine and Remifentanil infusions in groups will be increased by titration if MAP rises above 65 mm/Hg for more than 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Nicardipine | Active comparator | Nicardipine is a dihydropyridine derivative vasoselective drug. Rapid onset of action i.v. nicardipine is used when rapid control of blood pressure is needed. The potential role of i.v. nicardipine was shown in many cardiovascular and neurovascular surgical procedures and surgical procedures in which CH was performed with hemostasis (6). Receives: Procedure: Nicardipine |
| Remifentanil | Active comparator | Although remifentanil has unique pharmacokinetic properties, its pharmacodynamic effects are similar to those of other opioids. Remifentanil has dose-dependent analgesic, sedation and respiratory suppression side effects. All of these effects are antagonized by the mu receptor-specific opioid antagonist naloxone. Remifentanil has vagotonic and sympatholytic effects, and common side effects are bradycardia (heart rate <50 beats/min) and hypotension (SBP <80 mm Hg). Other common side effects are itching, nausea and vomiting, and chest wall stiffness after bolus administration (35).
The elderly population is more sensitive to opioid effects. It has been shown that it suppresses the delta wave in EEG due to the effects of opioids in the cerebral cortex. This feature is twice as common in the elderly as in the younger population. Receives: Procedure: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of the intraoperative surgical field
Quality of the intraoperative surgical field will be measured on a grade of 0-10 (0-1. no bleeding, 2-3. mild bleeding, 4-5. Mild to moderate bleeding, 6-7. moderate bleeding, 8-9. moderate to severe bleeding, 10. Severe bleeding)
Measured: Measurements will be made at four different times B1: Skin incision (initial stage of surgery), B2: mastodectomy stage of surgical intervention, B3: cholestatum cleaning stage of surgical intervention, B4: grafting phase of surgical intervention
Secondary outcomes (2)
Heart rate
Heart rate is measured as beats/minute on the anesthesia monitor
Measured: Measurements will be made at six different times T1: at the 20th minute of surgical intervention T2: mastodectomy stage of intervention T3: cholestatum clearing of intervention T4: grafting phase of surgical T5: first minute after extubation, T6: 10 min
Mean arterial pressure
Mean arterial pressure is measured as mmHg on the anesthesia monitör
Measured: Measurements will be made at six different times T1: at the 20th minute of surgical intervention T2: mastodectomy stage of intervention T3: cholestatum clearing of intervention T4: grafting phase of surgical T5: first minute after extubation, T6: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start30 Nov 2023 (estimated)
- Primary completion25 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Other Complications of Surgical and Medical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Prospective Randomized, Placebo-Controlled Clinical Tria
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erol Karaaslan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erol Karaaslan, Inonu University
- Investigators
- Erol Karaaslan, assoc prof, Study director, Inonu University Medical Faculty , malatya.turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130527
- Sponsor's protocol ID
- erolkaraaslan5
- Status last verified
- Nov 2023
- First submitted
- 15 Sep 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baker AR, Baker AB. Anaesthesia for endoscopic sinus surgery. Acta Anaesthesiol Scand. 2010 Aug;54(7):795-803. doi: 10.1111/j.1399-6576.2010.02259.x. Epub 2010 Jun 16.
PubMed 20560885Shin S, Lee JW, Kim SH, Jung YS, Oh YJ. Heart rate variability dynamics during controlled hypotension with nicardipine, remifentanil and dexmedetomidine. Acta Anaesthesiol Scand. 2014 Feb;58(2):168-76. doi: 10.1111/aas.12233. Epub 2013 Nov 22.
PubMed 24261345
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Nicardipine and Remifentanil on Surgical Visual Field and Hemodynamic Parameters in Tympanomastoidectomy Cases
- ClinicalTrials.gov ID
- NCT06130527
- Acronym / sponsor ID
- erolkaraaslan5
- Keywords
- Surgical visual field, nicardipine, remifentanil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Erol KaraaslanUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the present study, the purpose was to compare the effects of Nicardipine and Remifentanil on surgical visual field and hemodynamic parameters in microscopic tympanomastoidectomy cases with Controlled Hypotension (CH).
Detailed description
The visibility of the surgical field provides many advantages (e.g., preventing possible complications and reducing the duration of surgical application). In microsurgery performed in a closed and narrow area (e.g., middle ear surgery), even a small amount of blood may impair the quality of vision in the operation area and complicate the surgical intervention.
Controlled Hypotension (CH) is often preferred in some planned surgeries in reducing intraoperative bleeding, creating a quality surgical field, increasing surgical success, and reducing surgical complications. It is especially important to use it in interventions such as Functional Endoscopic Sinus Surgery (FESS), septoplasty, tympanoplasty, and vertebral surgery performed with microsurgery. As well as the advantages of CH, there is the possibility of causing various side effects by causing target organ hypoperfusion. Cerebral, renal, liver, and cardiovascular systems are the organs most affected by side effects.
Various hypotensive agents such as volatile anesthetics, sympathetic antagonists, sodium nitroprusside, nitroglycerin, hydralazine, trimethaphan, and α2 agonists are used in the literature to provide controlled hypotension.
Nicardipine is a dihydropyridine derivative vasoselective drug. Rapid onset of action i.v. nicardipine is used when rapid control of blood pressure is needed. The potential role of i.v. nicardipine was shown in many cardiovascular and neurovascular surgical procedures and surgical procedures in which CH was performed with hemostasis.
Its dromotropic effect is very low because nicardipine has no significant depressant effect on the conduction system and electrophysiological parameters of the heart. It undergoes substantial presystemic elimination in the liver after oral administration. For this reason, the rate of elimination does not change in patients with kidney failure. The elimination half-life is approximately 2 hours and slows down in patients with hepatic dysfunction.
Many studies investigate the effects of CH on surgical field image quality, surgical satisfaction, bleeding, and hemodynamic parameters. However, in our literature review, no study was detected comparing Nicardipine and Remifentanil in microscopic tympanomastoidectomy cases.
In the present study, the purpose was to compare the effects of controlled hypotension with nicardipine and remifentanil on the quality of surgical field visibility and hemodynamic parameters in endoscopic tympanomastoidectomy cases
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment Prospective Randomized, Placebo-Controlled Clinical Tria
| Arm | Type | Receives |
|---|---|---|
| Nicardipine | Active comparator | Procedure: NicardipineNicardipine is a dihydropyridine derivative vasoselective drug. Rapid onset of action i.v. nicardipine is used when rapid control of blood pressure is needed. The potential role of i.v. nicardipine was shown in many cardiovascular and neurovascular surgical procedures and surgical procedures in which CH was performed with hemostasis (6). |
| Remifentanil | Active comparator | Procedure: RemifentanilAlthough remifentanil has unique pharmacokinetic properties, its pharmacodynamic effects are similar to those of other opioids. Remifentanil has dose-dependent analgesic, sedation and respiratory suppression side effects. All of these effects are antagonized by the mu receptor-specific opioid antagonist naloxone. Remifentanil has vagotonic and sympatholytic effects, and common side effects are bradycardia (heart rate <50 beats/min) and hypotension (SBP <80 mm Hg). Other common side effects are itching, nausea and vomiting, and chest wall stiffness after bolus administration (35). The elderly population is more sensitive to opioid effects. It has been shown that it suppresses the delta wave in EEG due to the effects of opioids in the cerebral cortex. This feature is twice as common in the elderly as in the younger population. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II patients of both sexes,
- aged 18-65 years,
- scheduled for tympanomastoidectomy and decided to perform CH,
Key exclusion criteria (11 listed)
- hypertension,
- anticoagulant medication,
- pregnancy
- major hepatic,
- renal,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicardipineFollowing the intubation, the infusion was initiated by using an infusion device (Orchestra Base Primea, Fresenius Kabi) with an i.v. dose of 1.0 µg/kg/min iv in Group N. The targeted MAP was determined as 50-65 mmHg and drug doses were increased until the targeted MAP was achieved In Group N. Nicardipine infusion will be increased by titration in groups with MAP above 65 mm/Hg for more than 5 minutes. | Procedure or surgery | Nicardipine |
| RemifentanilInfusion was administered i.v. using an infusion device (Orchestra Base Primea, Fresenius Kabi). In Group R, the dose will start at 0.05 µg/kg/min following intubation. The target MAP was determined as 50-65 mmHg and drug doses will be increased until the target MAP is reached. HR more than 120 seconds and less than 45 beats/min will be considered as bradycardia and the remifentanil dose will be reduced. If response is unsatisfactory, 0.5 mg Atropine i.v. will be implemented. Nicardipine and Remifentanil infusions in groups will be increased by titration if MAP rises above 65 mm/Hg for more than 5 minutes. | Procedure or surgery | Remifentanil |
Primary outcome
Quality of the intraoperative surgical field
Time frame: Measurements will be made at four different times B1: Skin incision (initial stage of surgery), B2: mastodectomy stage of surgical intervention, B3: cholestatum cleaning stage of surgical intervention, B4: grafting phase of surgical intervention
Quality of the intraoperative surgical field will be measured on a grade of 0-10 (0-1. no bleeding, 2-3. mild bleeding, 4-5. Mild to moderate bleeding, 6-7. moderate bleeding, 8-9. moderate to severe bleeding, 10. Severe bleeding)
2 secondary outcomes
Heart rate
Time frame: Measurements will be made at six different times T1: at the 20th minute of surgical intervention T2: mastodectomy stage of intervention T3: cholestatum clearing of intervention T4: grafting phase of surgical T5: first minute after extubation, T6: 10 min
Mean arterial pressure
Time frame: Measurements will be made at six different times T1: at the 20th minute of surgical intervention T2: mastodectomy stage of intervention T3: cholestatum clearing of intervention T4: grafting phase of surgical T5: first minute after extubation, T6: 10 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 20560885Baker AR, Baker AB. Anaesthesia for endoscopic sinus surgery. Acta Anaesthesiol Scand. 2010 Aug;54(7):795-803. doi: 10.1111/j.1399-6576.2010.02259.x. Epub 2010 Jun 16.
- Results publication: PubMed 24261345Shin S, Lee JW, Kim SH, Jung YS, Oh YJ. Heart rate variability dynamics during controlled hypotension with nicardipine, remifentanil and dexmedetomidine. Acta Anaesthesiol Scand. 2014 Feb;58(2):168-76. doi: 10.1111/aas.12233. Epub 2013 Nov 22.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erol Karaaslan, assoc prof study director
Inonu University Medical Faculty , malatya.turkey
Questions about this trial
What is this clinical trial studying?
A study testing Nicardipine and Remifentanil in people with Other Complications of Surgical and Medical Procedures, run by Erol Karaaslan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erol Karaaslan, assoc prof (+905322034830 ext. Turkey, erkara44@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of the intraoperative surgical field (time frame: Measurements will be made at four different times B1: Skin incision (initial stage of surgery), B2: mastodectomy stage of surgical intervention, B3: cholestatum cleaning stage of surgical intervention, B4: grafting phase of surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06130527, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.